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Allergy medication in Japanese volunteers: treatment effect of single doses on nocturnal sleep architecture and next day residual effects.
Curr Med Res Opin. 2006 Jul; 22(7):1343-51.CM

Abstract

OBJECTIVES

To evaluate the acute effects of two histamine H(1)-receptor antagonists on nocturnal sleep architecture and on next day cognitive function and psychomotor performance.

METHODS

This was a single-site, randomized, double-blind, 3-way crossover study, comparing the effects of a single dose of chlorpheniramine (6 mg), fexofenadine (120 mg) and placebo in 18 healthy (male and female) Japanese volunteers aged 20-55 years. Volunteers were resident for 3 days and each period was separated by a minimum 5-day washout period. The three treatments were administered at 23.00 h. Overnight sleep was measured from 23.00 h to 07.00 h using polysomnography. Residual effects were studied at 07.00 h and 9.00 h the next morning, with the latency to sleep (sleep latency test) measured at 09.30 h.

RESULTS

Compared with placebo, chlorpheniramine increased the latencies to sleep onset and rapid eye movement (REM) sleep (p < or = 0.05 for both), and reduced the duration of REM sleep (p <or= 0.01), but this was not observed with fexofenadine. As far as residual effects the next morning were concerned there were decrements in performance with chlorpheniramine, but not with fexofenadine. Chlorpheniramine 6 mg impaired divided attention (p < 0.001), vigilance (p < 0.05), working memory (p < 0.0001) and sensori-motor performance (p < 0.01), and the latency to daytime sleep was reduced (p < 0.0001). Six adverse events possibly related to study medication were reported during the study, three of which were related to placebo, two to fexofenadine and one to chlorpheniramine.

CONCLUSION

These findings suggest that a single nocturnal dose of fexofenadine has advantages over the first-generation antihistamine chlorpheniramine, being free of disruption of night-time sleep and detrimental effects on cognitive performance the next day. It is likely that this advantage will remain with chronic ingestion, but this would need to be confirmed.

Authors+Show Affiliations

HPRU Medical Research Centre, University of Surrey, Guildford, UK. j.boyle@surrey.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16834833

Citation

Boyle, Julia, et al. "Allergy Medication in Japanese Volunteers: Treatment Effect of Single Doses On Nocturnal Sleep Architecture and Next Day Residual Effects." Current Medical Research and Opinion, vol. 22, no. 7, 2006, pp. 1343-51.
Boyle J, Eriksson M, Stanley N, et al. Allergy medication in Japanese volunteers: treatment effect of single doses on nocturnal sleep architecture and next day residual effects. Curr Med Res Opin. 2006;22(7):1343-51.
Boyle, J., Eriksson, M., Stanley, N., Fujita, T., & Kumagi, Y. (2006). Allergy medication in Japanese volunteers: treatment effect of single doses on nocturnal sleep architecture and next day residual effects. Current Medical Research and Opinion, 22(7), 1343-51.
Boyle J, et al. Allergy Medication in Japanese Volunteers: Treatment Effect of Single Doses On Nocturnal Sleep Architecture and Next Day Residual Effects. Curr Med Res Opin. 2006;22(7):1343-51. PubMed PMID: 16834833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Allergy medication in Japanese volunteers: treatment effect of single doses on nocturnal sleep architecture and next day residual effects. AU - Boyle,Julia, AU - Eriksson,Malin, AU - Stanley,Neil, AU - Fujita,Tomoe, AU - Kumagi,Yuji, PY - 2006/7/13/pubmed PY - 2006/8/30/medline PY - 2006/7/13/entrez SP - 1343 EP - 51 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 7 N2 - OBJECTIVES: To evaluate the acute effects of two histamine H(1)-receptor antagonists on nocturnal sleep architecture and on next day cognitive function and psychomotor performance. METHODS: This was a single-site, randomized, double-blind, 3-way crossover study, comparing the effects of a single dose of chlorpheniramine (6 mg), fexofenadine (120 mg) and placebo in 18 healthy (male and female) Japanese volunteers aged 20-55 years. Volunteers were resident for 3 days and each period was separated by a minimum 5-day washout period. The three treatments were administered at 23.00 h. Overnight sleep was measured from 23.00 h to 07.00 h using polysomnography. Residual effects were studied at 07.00 h and 9.00 h the next morning, with the latency to sleep (sleep latency test) measured at 09.30 h. RESULTS: Compared with placebo, chlorpheniramine increased the latencies to sleep onset and rapid eye movement (REM) sleep (p < or = 0.05 for both), and reduced the duration of REM sleep (p <or= 0.01), but this was not observed with fexofenadine. As far as residual effects the next morning were concerned there were decrements in performance with chlorpheniramine, but not with fexofenadine. Chlorpheniramine 6 mg impaired divided attention (p < 0.001), vigilance (p < 0.05), working memory (p < 0.0001) and sensori-motor performance (p < 0.01), and the latency to daytime sleep was reduced (p < 0.0001). Six adverse events possibly related to study medication were reported during the study, three of which were related to placebo, two to fexofenadine and one to chlorpheniramine. CONCLUSION: These findings suggest that a single nocturnal dose of fexofenadine has advantages over the first-generation antihistamine chlorpheniramine, being free of disruption of night-time sleep and detrimental effects on cognitive performance the next day. It is likely that this advantage will remain with chronic ingestion, but this would need to be confirmed. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/16834833/Allergy_medication_in_Japanese_volunteers:_treatment_effect_of_single_doses_on_nocturnal_sleep_architecture_and_next_day_residual_effects_ DB - PRIME DP - Unbound Medicine ER -